Three-year results of a multicenter prospective study of transoral incisionless fundoplication.

BACKGROUND: To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting. METHODS: A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1 and 3 years consisted of symptom evaluation using the GERD health-related quality of life (GERD-HRQL) questionnaire, medication use, upper gastrointestinal endoscopy, and pH-metry. RESULTS: Of 79 patients previously reported at 1 year, 12 were lost to follow-up, and 1 died from an unrelated cause. The remaining 66 patients were followed up and analyzed (mITT). Of 66 patients, 12 underwent revisional procedures, leaving 54 patients for PP analysis at a median of 3.1 years (range = 2.9-3.6). No adverse events related to TIF were reported at 2- or 3-year follow-up. On PP analysis, median GERD-HRQL score off proton pump inhibitors (PPIs) improved significantly to 4 (range 0-32) from both off (25 [13-38], P < .0001) and on (9 [0-22], P < .0001) PPIs. Discontinuation of daily PPIs was sustained in 61% (mITT) and 74% (PP) of patients. Of 11 patients with pH data at 3 years (PP), 9 (82%) remained normal. Based on mITT analysis, 9/23 (39%) remained normal at 3 years. CONCLUSIONS: The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability.

Thoracoscopic esophagectomy in prone position.

INTRODUCTION: Esophagectomy can be performed by different minimal invasive techniques. We report a technique of Ivor Lewis esophagogastrectomy with manual anastomosis performed by thoracoscopy in prone position. Readers are encouraged to view the streaming video that accompanies this article. CASE REPORT: A 51-year-old man was consulted for adenocarcinoma of the distal esophagus without lymph nodes invasion. Anesthesia was realized using a double-lumen endotracheal tube. The procedure started with the patient supine, and five abdominal trocars were placed. Celiac lymphadenectomy, wide Kocher maneuver, and pyloroplasty were performed. A wide gastric tube was advanced through the hiatus into the right chest. Subsequently the patient was placed in prone position and three trocars (two 5-mm, one 10-mm) were placed in the 5th, 7th, and 9th right intercostal space. The intrathoracic esophagus was dissected, and mediastinal lymphadenectomy with en bloc resection of the left inferior mediastinal pleura was performed. After sectioning the azygos vein, the esophagus was transected by scissors 1 cm cranially. A completely thoracoscopic manual double-layer anastomosis was performed using running sutures with PDS 2/0 (externally) and Maxon 4/0 (internally). Finally the patient was replaced supine; the gastric tube was fixed to the hiatus, and the specimen was retrieved by suprapubic incision. RESULTS: Thoracoscopy lasted 157' (anastomosis 40'), laparoscopy 160', and second laparoscopy 20'. Blood loss was 170 cc. The patient was discharged on postoperative day 6. CONCLUSIONS: Thoracoscopy in prone position allows the surgeon to perform a thoracoscopic esogastric anastomosis completely manually using only three trocars and without selective lung desufflation.

Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using EsophyX.

BACKGROUND: A feasibility study (n = 19) evaluated the safety and initial efficacy of transoral incisionless fundoplication (TIF) for the treatment of gastroesophageal disease (GERD). The results at 1 year (n = 17) indicated that TIF was safe and had a significant effect on reducing GERD symptoms, proton pump inhibitor (PPI) usage, acid exposure, and small hiatal hernia. This study was designed to evaluate the long-term safety and durability of TIF. METHODS: Fourteen patients (50% female; median age, 34 years) completed the 2-year follow-up assessment tests. Three patients were excluded from the study after 1 year because two of them underwent retreatment and one was lost to follow-up. RESULTS: At 2 years, no adverse events related to TIF were reported. A >or=50% improvement in GERD-HRQL scores compared with those at baseline on PPIs was sustained by 64% of patients. TIF was effective in eliminating heartburn in 93% of patients and daily PPI therapy in 71% of patients. Significantly (p < 0.05) more patients were able to consume reflux-causing foods and maintain lifestyle activities without GERD symptoms compared with baseline on PPIs. Fundoplications were durable and maintained their geometric dimensions. TIF was effective in eliminating hiatal hernia in 60% of patients and esophagitis in 55% of patients. Global assessment of all outcomes in each patient revealed that 79% of patients experienced complete cure (29%) or remission (50%) of GERD at 2 years after TIF. CONCLUSION: The results at 2 years supported the long-term safety and durability of TIF and its sustained effect on the elimination of heartburn, esophagitis,

Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study.

BACKGROUND: A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial. METHODS: Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm. RESULTS: The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2-6 cm) and 230 degrees (160 degrees -300 degrees ). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with >or=50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation. CONCLUSION: The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.